FDA (Devices) recall action 93486
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Biomet's Biolox ceramic hip implant heads were shipped with the wrong adapter component. The adapter had an incorrect neck length (M/+0 instead of S/-3.0) that differs in size marking.
Biomet is recalling a hip implant adapter lot due to incorrect packaging containing the wrong adapter specification. The mismatch could result in incorrect implant selection during surgery if not detected before use.